ICPT - Earnings call transcript Q3 2021 | Intercept Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Q3 2021 Intercept Pharmaceuticals Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. I will now turn the call over to your host, Lisa DeFrancesco, SVP, Investor Relations and Corporate Affairs.

begin. may You

Lisa DeFrancesco

which morning today's Good release you joining financial for our site our Thank www.interceptpharma.com. at This and morning, on position, and results call. quarter press available we us on third Web you. XXXX thank is issued announcing a

statements, financial we discussion, program, approved our prospects, to these Listeners and our product clinical development I'd Before regulatory commercial note call, matters, our strategy, regarding during begin to including and be will statements our certain financial and cautioned we are on making forward-looking risks are These inherently place are believed like future that guidance a based forward-looking statements, obligation only and reliance undue performance. not no to reasonable, date the update assumptions to number to of on such be estimates forward-looking of statements and uncertainties. as of that, law. this which statements although uncertain And by undertake speak call. subject we except and and as required

Development necessarily not Risk discussed Officer, release begin materially cause actual results all, Chief Chief with our the and but and and remarks this CEO, predicted are President our our press Medical in filings Some, Chief public Richardson; Berrey; with Jerry Officer, in Saik. Michelle periodic Financial Commercial call could SEC. forward-looking and the from or differ morning's our Today's Research historical will of Durso; prepared Dr. by prerecorded statements our results President Andrew Officer, from anticipated and Factors Linda our or to that those of

Paul President, Please Pharmacovigilance; are to be Senior President purposes Q&A & Cawkwell, questions to Nitschmann, allow all today Dr. initial for limit one in yourself Senior Safety Affairs, Affairs. question order Vice time Vice Additionally, addressed. available Regulatory and Medical Gail to for Dr.

me now Durso. CEO, call turn over the our Jerry? to Jerry Let

Jerry Durso

you call. everyone. morning, good and on conference earnings Thank third quarter for XXXX us Lisa, joining Thanks, our

as the made year to the the I like my we the we've XXXX, out that would start reflecting near objectives of close CEO As to this against of start main and at first of that year. we on progress achieve set by Intercept, great

First, regulatory our forward. progressing portfolio development pipeline; foundational improve NASH; fibrosis our including our and due with internal our execute and program and financial clinical our to growing to third, Ocaliva; path PBC to on to goals, in to our support clinical second, and continue advanced business our finally, our operational to foundation advance expand

Ocaliva. the objective, in PBC resiliency and driving of our strength to Regarding growth our see first we business, continue

since third last quarter of the the As quarter was sales label of May. year, updates end a reminder, full quarter U.S. We first were XX% and over third growth about as the reported at quarter few the to finalized remainder the In the Linda details our for commercial and sales year. minutes, the will have performance additional of a year. our and our share a guidance result increased Andrew outlook for third

made also of the with data will goals, Now data believe generate expand to We've our the accelerated that advanced pre-submission in have And We progress into continue of NASH the generation a FDA process anticipate in NDA NASH. have this if continue a determine NASH. label due data clinical XXXX. path the treatment be to in for program I part fibrosis package of the data half the first in our for the on and support our goal and the largest strong to support conviction would OCA executing of we our approval, forward to next to our These early during important meeting target year. could grow business great long update worked ability field our remain U.S., regulatory and we've on through our potential to resubmission term.

this pipeline line We and compensated with our near opportunities also X portfolio by leverage looking cirrhosis end from for also to expand due Phase advancing of to our working our anticipate trial, NASH We've data is strengths. the OCA which top patients in year. REVERSE our been assessing to

announced for we've quarter, initiated progress As work on the will our last bezafibrate advance continue INT-XXX our we and more agonist generation our in Phase PBC. next study programs. Michelle these across first-in-human share X the OCA for to details program FXR combination

operational operating great We've and reduced addition expense prudent foundation. progress with objectives, remained to morning. our cost significantly announced also on we that our making our guidance structure, in this this the in Importantly, year's narrowed and we've strengthened expenses financial resulting

maturity the as This we're a debt path our we do and in Intercept's for and cash pursuit approval in our supportive the exchanged of successfully a growing Furthermore, and a or the another either notes. previously said, convertible also if with majority of profitable near-term of we we've phase we journey, company's of strategic steps the future. position where quarter. will cash burn be disease data These strong enter could support as critical it, on rate, the data-driven We XXXX reduced NASH focus to the are be defining address positive next rare path making of decisions not accelerated the business. significantly

successful our Linda will focus over review with commercial our long performance of on our will allow to R&D going And to strong the update will Linda? quarter. With Andrew provide us who regulatory becoming then conclude Our I'm about and will over talk term. performance. a solid activities. an to company financial on that, this it turn foundation a Michelle

Linda Richardson

today. time Thanks, to and us everyone who's Jerry, thank you making to join

release U.S. the the you and quarter third once in in performance demonstrated international and foundational solid business year-to-date As our press both our periods. again this PBC markets in saw morning,

impact label we earnings And last I'll the call, on providing our in During third U.S. now. that some the business this in we see be the to indicated change expected of our commentary quarter.

the reached following our professionals educate label. Ocaliva the sales our first fully pivoted teams now, for to effectively medical eligible patients. as First, the the U.S. new within commercial promoting healthcare months of affairs on and We label. job a And three back targets prescribing has receipt to great worked did revised team they our

data show our weekly a impact. patients twice who are are treatment the should which the given or lower our of patients These regimen discontinuing are on discontinue, has Second, labeling. volume who many dosing, of a Ocaliva once revised that

report ultimately impact our who update Third, with Ocaliva. were Physicians label the by will before population, implementing noted believe reactions change. post that estimated label change. we we that At patients population assess earlier the updated when range. treatment there had a with cirrhosis of have is of on undertaken this the decompensated end feedback update. that this will time label year. that team, current Ocaliva be to impacted. We've market trends, research are gastroenterologists to that of had end existing appropriate for understand of the impact We be in not lower the patients largely Ocaliva seeing has sales label we impact the patients particular, they label, at new was on and which label this beyond typically been significant can label realized anticipate projected provider the treating and Therefore, community patient they XX% of the through encounter less could to the discussions revised based their healthcare Furthermore, be sometimes the not that selection on consistent. are aware the year, you our our XX% the who Furthermore, label

label are the beginning we which change. forward, of through we patient new Moving since weakened now COVID on and the focused starts, have seen

patients label trial. to community beyond data is requiring continue in who feedback the extension data cohort progressive for that materials We of POISE five begin core stabilization Ocaliva healthcare disease fibrosis see given we In in of data patients September, with educational significant our very our show treatment therapy majority second-line remain of over eligible providers prescriber compelling highlight business, PBC, new new a fundamental been The our with positive. resonating to to messaging. remained PBC Ocaliva. vast phase sharing is stabilization PBC has opportunity a ALP our These of a the like years. from ability and our with the open In share

solid as another up quick year. business a last compelling sales Just XX% had our over performance word international on was quarter we

as Dr. us, to will of of our XXXX. do and for Berrey. continue We new starts this increase adoption Ocaliva excellent patient of in strong focus sales follow through which year. the this to turn The and guidance in see in call year, the anticipate his last to time, in performance us At Multi-channel quarter with discuss strong for late to with increasing compared growth regions. experience I'll we label has Michelle? commercial the in our to We change markets led third overall XXXX international the a implementation been over across engagement has our execution section call. Andrew teams customers a Michelle

Michelle Berrey

Linda, and morning, you, to updates a provide I'd few Thank good today. like key everyone.

First, generation track. I'll data our an NASH interactions on remain you with which and regulatory update on provide

of our exciting Second, and we PBC. And preview requirements I'll quarter. with some I'll important activities. data with NASH. on currently we we outlined where Meeting marketing you important regarding update data on upcoming begin at other progress sharing post pleased say pipeline last track we're in some I'll our be generation with share some I'm lastly, will are the the Liver to

of will now our than double interim include analysis than for patient with patient database NASH Our X,XXX initial safety years. the exposure OCA more more at

biopsies reading outlined On new reading consensus the currently month our baseline XX and efficacy we methodology liver last front, all using quarter. that we're panel

NASH XXXX. support to fibrosis, a expect the the this of the of in we of into early largest the continue in created ever are generating NDA to midst process potential field and part data We in resubmission package NASH our

these due U.S. study to NASH. an approval data treat we advanced the the a to in for as pursuit REGENERATE fibrosis As of OCA accelerated the generating reminder, are first from in compound

study liver also patients Phase large have REVERSE, in X for studying We with our begun cirrhosis. OCA NASH second compensated reading biopsies

complete be end to process line data and year. that to expect this be We REVERSE around the from of available top

FDA we able half As meeting of data we expect support hold XXXX. long the will be first the to pre-submission a as it, with in

had We of to top data for granted to MAA remains priority NDA. were a U.S., potential file. clock subsequently application. the our the were for stop We advantage our Europe support we resubmission generation in take important our and requested conducting EMA for a fibrosis generating this remains record data While our NASH on also in

this planning our are Day respond We now XXX to to questions month.

not attempted generation efficacy position made initial will progress and and strong two as commitments. we're that to submitted of relevant the Network, complications for patients in of U.S., overall align and like or marketing given data reminder, EMA, made the guidance unmet FDA ongoing EMA data And our update results in Day XXX reversal on again association their between outlined to Discussions at that would they of high preference marketing Medicine continue totality bar recently a both this CRN, their clearer. published risk regulatory And processes, for stage EMA draft a England NASH. improvement. we've never regarding an and will some two now, of and NASH The While these and has they progress. into the reflection increased will therapy paper NASH NASH XXXX. studies seeing fibrosis both provide been responses a XXXX. PBC the an liver-related clinically filings. development our and include has all important or a a and be fibrosis with driven final clinical that with expressed our stated the anti-fibrotic study following significant dossier for we've New in clinical Journal from from in Research resolution post of looking be statistically efficacy clearly for generating NASH But the outcome also The in remain advanced need death the post NIH's the in reinforces prospective that data review Clinical I'd fibrosis and

placebo blinded, reminder, Ocaliva have regulators, for potential and Ocaliva is COBALT next retaining gathering acknowledged studies, in in is in step XXXX, to since approval PBC study. we from the the difficulties process feedback a the time controlled patients of After when commercially in close out available. that our As these recruiting the

dialogue include work available from COBALT collect we extension it include world with package from will one controlled data will package fulfill EMA, real evidence POISE will the and as of evidence study. post and and element data our also broader outcomes commitments data We This marketing a to and our long-term obligations. that FDA inform placebo as

we're AASLD package The and expect our generation We for that been this our take the proud one And to podium of abstracts data late-breaker note, not only submit on to selected presentation long-term several but at to in groups. survival XXXX has best global as share of data in that patients process quarters XXXX. external plan today The setting PBC abstract the primary a is Meeting, with obeticholic study better with cholangitis transplant-free Liver acid controls trial from abstract. demonstrate treated UK PBC than biliary entitled and a

We all use remains these sharing only PBC about a November patients in demonstrate for you the and are excited XX. approved with agent Ocaliva data disease. continues with this devastating on second-line benefit to to

We working post to encouraged come marketing I'm are to by and resolution closely progress our the committed thus to with regulators commitments, regarding a far.

trial to pipeline, OCA plus our is the U.S. our Phase X bezafibrate outside to Turning continuing enroll

phos for alk this the and supporting associated of combination bezafibrate data are with and and reduce survival. potential improved reinforce bilirubin to encouraging PBC benefit published elevated the We novel previously, a Phase X shared we've therapies remain an committed PBC. combination that be living for range U.S. to individuals in study of measures additional will the plan in to of As with trial initiated broader the We progressing

our generation progress for indication we target our FXR Overall, look INT-XXX INT-XXX R&D pipeline XXXX. in our X of updates as select I'm programs ongoing. kick sharing next with our We off made to Additionally, team pleased plan is I has a XXXX. to the forward agonist and Phase early on study

President, due over I Cawkwell, Medical when Dr. able let back Paul an help know the Before week Affairs your in session call unfortunately be I've Andrew, Safety you Senior President the from not would personal next Vice my Nitschmann, asked Vice turn join unavoidable office. Regulatory will team like to I the matter. following look to Q&A Gail that I answer Pharmacovigilance; today to & all to Dr. with and Senior you I'm I to Affairs, questions. to forward up

call financial the over to Andrew? turn update. a for I'll Now Andrew

Andrew Saik

today everyone. and of September for release ended that Michelle, was I our quarter summary Thanks, earlier good our ask press results to XXXX. please financial issued third would morning, refer to a for performance and of quarter quarter, prior XX, in million this worldwide second compares sales $XX.X XX.X year This Ocaliva we million. in XX.X Beginning this year. sales million the recognized with the of net to period the

in As of quarter is of a our quarter Ocaliva this May the new following first was implementation third reminder, the year. of XXXX the which finalized label,

$XX.X and represents of and are net This XX% sales growth respectively, ex-U.S. the U.S. of Ocaliva worldwide net quarter. of Our prior comprised versus XX%, approximately sales $XX.X million of sales million. year

our versus was quarter, expenses demand year. Our well, $XX quarter year million of operating the U.S. business business decrease performed versus as a XX.X million million the Non-GAAP last adjusted for expenses relative third totaled operating which XX.X million, quarter last the Linda results decrease were of discussed year solid the from growth by increased global was $XX.X period. the Overall, third for prior performance. prior year. a and benefit reflect and international mix business GAAP to driven earlier, a over country a

decrease Cost were of reflects $X.X sales year XXXX. related of period As million non-GAAP the third compared versus operating for the the year compared $XX.X to the in adjusted purchases of of quarter packaging, $X.X from compensation timing quarter, this other million stock-based labeling, depreciation. year. second were and and quarter the the the expenses the and prior SG&A million prior expenses of during our a third X.X a of to This period. excludes a third decrease quarter $XX.X decrease expenses million of reminder, API, million for

million million, a quarter third in expenses of same year. the last X.X from the were decrease period R&D Our $XX

for we a fourth to early higher and relative for relative datasets this expenses quarter in We Michelle. expect later in by than spend operating QX anticipate discussed This year. be of prepare due and as XXXX release what normal as is the next R&D year, next to higher to will we year the

net driven of two stock cost. a in performance cash investments, expenses. expenses increase our months R&D quarter. highlights our NASH-related during positive of adding in was continued PBC XXXX, operating and new this and than expenses excludes strong and profitability our QX, from the R&D ended cash with foundational for which We were large exchange, the of ended operations the Even in nine representing with higher second we our international the For debt R&D by the XX, approximately million impact position repurchase This QX U.S. focus September issuance on sales $X debt both NASH million were consecutive $XXX.X which quarter, managing the total cash thirds franchise.

as totaled and million. cash cash, $XXX.X investment Our XX, XXXX September of restricted debt securities approximately cash equivalents,

with our previously of be million increasing million of performance impact will the $XXX our strong net of Ocaliva shared result change million and a the are on knowledge label $XXX low from to $XXX expectations, the to million. global end sales $XXX the the our As guidance that we to

We now are $XXX between $XXX to $XXX and to previous $XXX to and million. million of guidance, compared million expense million our also narrowing our guidance expenses expect be as operating operating

generating and on top important has it this priorities ability Since able convertible near-term exchange, with exchange hand. gives Between for data that Lastly, private maturity and remain to joining which transactions, our strong in financially to define my well our note on cash path a ensure debt. we debt notes the manage subsequent us the to allows our to growing us year, we were execute one business to manage earlier near-term This to in focus the maturity PBC been and repurchase $XXX of successfully we Intercept million, growth. $XX of forward. XXXX our positioned debt a our to lowered million of NASH

this PBC regulatory and execute significantly a have on strong expand portfolio cash sheet utilize pipeline. and balance ensure and our year, support our our clinical have sheet continue balance milestones, to prudently to franchise, and we to our flexibility the foundational and de-risked our have will that We we

the it Now to back I'll over turn operator to start the Q&A.

Operator

[Operator Instructions].

limit Cowen. question Baral to Ritu question and get from back to accommodate one everyone that comes ask also in with our you We free first to yourself the queue. feel And

Anvita Gupta

the for the far? safety morning. biopsies data Good morning, Could on thus reevaluated Congrats XX-month progress this reading trial. patients Ritu get do great We follow-up team. have on biopsies details many of quarter. the how you many some This Anvita comment you. from is to of you the how Thank date? on to the you wanted have And REGENERATE on

Jerry Durso

Yes. to work at And areas lot here Intercept the a Thanks thanks the mentioned. who's for you question. Hi. doing that team the of in

So the has remarks. work ongoing. the outlined the biopsies. we been XX-month And last The biopsy baseline focus on ongoing potential reads accelerated is discussion prepared really in stay approval ongoing as of we work as we stated the on are and towards reads quarter, as the

is that's that Again, So the and for XXXX. at is again, the accumulation The outlined quarter in data, last more than twice was ongoing the that time. population, in back work. is analysis indeed initial safety database the the of that the we same that

is that all work of So ongoing.

monitoring we've part on on are, into weekly we that this basis. sit early that will here and And result today, a as an outlined do expect, work being We continue would XXXX. completed package basis, we that the as of ongoing ultimately data you work that and in the expect continues

Anvita Gupta

Thank Great. you.

Operator

comes with next Sandler. Our Yasmeen question Piper from Rahimi

Swapnil Malekar

Yas. Great. Thanks. on This is Swapnil for

are the for event patients OCA abstract, your for treatment. you rates Just the show late-breaking significantly one that PBC us. question lower AASLD In on

PBC the patients. lower XX than think PBC and I UK like global it's

to parallel we ongoing database? So trial tell we the can kind this only read patients through NASH can from can what these many cirrhotic? us you draw of And of how [ph] were

Jerry Durso

And, AASLD. turn Gail. important course, we for the I'll coming of So the forward thanks over look to question. discussions at to that

Gail Cawkwell

Yes.

So thanks the question. for

at study, an that That looked earlier the was long-term safety we study. study extension POISE database, in internal largely PBC population. an So both

study, so were at some few patients. cirrhotic And there baseline in but that

of that more to careful the numbers course low patients to Over overall. matched propensity both match we like-to-like When provide use of but can there we in the score the were of study, criteria of and pseudo-randomization again the to inclusion you were the the very sort study in following POISE were to setting. comparing were from as that and study, external controls, we exclusion element an cirrhotic relatively still so

are to we in results at AASLD. the and sharing over like detail feel week forward interesting more just look we in a So them

Swapnil Malekar

Thank you.

Operator

Thanks.

with question next Our Lee Jefferies. from comes Michael

Michael Lee

hear Thanks. -- me? Hi. My morning. Good question is you can

Jerry Durso

Yes.

Michael Lee

that of guys effect guys. The Okay, And expect you is release question FX/FX that's on just the you be great. all that can remind doing put that we'll work you the to could that how continuing would 'XX. And and you and My greater? Thank just be early you you us could that submitting digest remind a data you less Can maybe expect or the would be could is, could My play of inclusion us the patients, contextualize put that what and more reassessment the efficacious? out you. effect time. Hi, press analysis that out just that better be around data FDA? question same? that? of at and information? The to Could on with are the color some

Jerry Durso

Yes, for question. Mike, the thanks

start I So on that can one.

Nonetheless, interpretation outlined, it the on as this think a importantly, is a new a work with FDA’s is again, new those method consistent of we've approach. is a of methodology. methodology with with the do the robust we think as the biopsies. believe for a build we that's analysis, is direction ongoing which We interim the consensus are and going result analysis, robust rereading method, robust prior was to I

appropriate is picture XXXX. the work course, the won't the at work information into once that we we'll appropriate is And, Of share complete completed. course, of completed time have till that

seeing we'll complete. when Importantly, forward look dataset it's to the

Operator

Thank you.

Brian RBC Abrahams from Capital comes Markets. with Our next question

Brian Abrahams

much taking question. my Hi, very you guys. Thank for

Jerry Durso

Brian. morning, Good

Brian Abrahams

us could good hi, If morning. you -- give

understanding was around any the to we're -- to that analysis? safety of that [ph], and going in AEs to If cardiovascular, give ongoing hepatic us roll you adjudication the is now. renal to of could Our start going update some on start

the totality on as at level FDA? side? the as decision and be going what's guiding meeting? confidence look for any a your So efficacy not where you to safety, of not to safety or situation you of go would the to there the to approach FDA whether Thanks. just wondering pre-submission back your And Is

Jerry Durso

one adjudication. start perhaps So on remind I'll the areas that on in can then thanks, and of ongoing Brian. everyone the Paul work

reminder, by As benefit. that the the time question overall at was posed FDA complete the was overall a the of risk letter around response

of And so complete context the year. the in which make step against position in And been it's then it's us we we’ll had hand, based Obviously, be really what earlier And an a that we data obviously, that that going to see the And in expect good data. we're we're important the series path with that, in first decisions step be be potential and which of we we a FDA assess on would were in outlined generate. with interpret if first in we pre-submission of data picture that the we half now discussion would interactions interpretation need this with I in and in think that to the agency after generation that to data about that would process. comprehensive the to going data that XXXX. put the potential would

be for we of part remind work important will understanding be importantly, will the digesting continued on that give to maybe this to move you next and the want believe areas picture here. Paul, of adjudication, ongoing So the the us which us. dataset

Paul Nitschmann

you, Thank Jerry. Yes.

So you're right.

and adjudication able all point, in renal and to is at the nothing the we a that hepatic cardiovascular ongoing. and And there having assess the share highlighted work the times ongoing of be arena. have And risk that. Jerry year. can will this next early we benefit couple about it's We now, It's about will are as really has

Brian Abrahams

Thanks much. enough. Fair so

Jerry Durso

Brian. Thanks,

Operator

question Young next Cantor Our comes with from Alethia Fitzgerald.

Emily Bodnar

Alethia. Emily you're Hi. on question. and given study latest for This data the about your there, see our on approach. looking curious to Thank new thoughts is consensus I'm REVERSE taking just the you. what Thanks for

Jerry Durso

couple It's work then remind important study. me high That at outlined. as so compensated. reads an that the thanks and Maybe with the a are cirrhosis an well of ongoing question, as maybe happening from patients These population. parallel, just words can we've important Emily. in REVERSE Paul So obviously is We are risk for dataset. the are of look

again, a consistent what We REGENERATE context. approach, are in utilizing consensus the with talked we about

monitoring REVERSE comment, this is role positive, look OCA think there's last just and so that to to to perhaps to look understanding the the on high the this study I is, evident, the population. is a the forward unmet We need important design this this we potential give clear do of again, we're thumbnail can and ongoing that risk the we the in I design. where And me readout Paul, and you closely. on information forward we is dataset. as is believe additional real at AASLD patient gives some If forward it is importantly, the work think options. look again, data point a for us

Paul Nitschmann

you. Jerry. Yes, Thank

or controlled. you uses poster primary said study for three and have well as XX [indiscernible] the already, groups. patients fibrosis than REVERSE a So as And dose -- AASLD one with a The placebo with compensated and a and at Phase improvement. said, study. NASH you will study XXX is equal months, greater going at stage a offset one to it's endpoint straight is The histology X titration One XX study it describe looks is arm XX is in a a is to milligram, cirrhosis.

Jerry Durso

Emily. you, Thank

Emily Bodnar

Thanks.

Operator

Needham Stringer & Our with Joseph next comes question Company. from

Joseph Stringer

questions. here. PBC taking Question and morning Good for our thanks on Hi.

going have give those do think idea Just sort be you you you you. if operating an can quarters next of of margins OCA your forward? for a Thank PBC? what over of of couple curious And current sense what us maybe are or couple years? and a Do improve could you those specifically the could for

Jerry Durso

obviously quarter. feel the in about question. the the in good PBC We Thanks for performance

also the have the a on PBC give some you front? on maybe basis, described a fact that color standalone We is that additional franchise one. can Andrew, profitable

Andrew Saik

question. thanks And for certainly. Yes, the

is The se. don't break PBC business PBC. we So a out business per

sales and the our product. P&L. cost the see You can are sales These [indiscernible] obviously on of

So clean numbers. those are

to We before R&D majority of are our expenses also NASH. related the that stated

As NASH of million. those of were R&D thirds XXX.X are QX year-to-date, related. expenses Approximately two

the sufficient So that break at trials that currently helps. data what of out of like that X for providing should information end process look business we're to the the the would NASH the quarter. in Hopefully give you significant without Phase

Joseph Stringer

for taking our Thanks question. Yes.

Operator

Richter next Sachs. Our with from Salveen question comes Goldman

Salveen Richter

could morning. question. the for just Good Could help presented us the whether might Meeting Liver be taking here data? there Thanks to understand be and at reevaluation upcoming my you through any what read

Jerry Durso

-- I'll that turn So to Gail Gail.

Gail Cawkwell

question. happy Sure. to take I'm that

So as will certainly Michelle AASLD. our that be I think some of we're initially, said excited at data

the first as is outcomes, data said that with course, new NASH. showing and accepted independent and doing PBC also there. is on data And methodology transparency outcomes data biopsy obeticholic And presentation, how advance, will but some the notable works things which be the have finally, as that we reading We’ll were provide we This of earlier, It's in breaker once the to Meeting oral of data several will is baseline used independent important release an well in established abstracts on methodology abstract. interesting on best gratifying Michelle coming Liver people and REVERSE Specifically, start will which showing not reading biopsy REVERSE also research. medicine obeticholic methodology acid; there some acid, some later. late data saw have there. and data

notes to amongst decompensated lower cirrhosis that compared approval before with that liver is approval. abstract and patients University Stanford PBC waitlist a Ocaliva since transplant, example, For mortality Ocaliva

encouraging. course, of is, this Now

control safety definitive, a work not we'll else And makes our up extension external the think data. NASH is pairing work excitement with at but out comes in little what to just on it While own I POISE that mainly I trial to see have on the long-term and But clinical a nice for NASH the setting. there's field that of meeting. side, think and emphasizes notable be certainly hard the successful

Salveen Richter

Thank you.

Operator

with comes question next from Merle Our UBS. Ellie

Ellie Merle

guys. question. taking for Hi, Thanks the

data the us rereads Just plans as additional on guess are statistical analyze your biopsy resolution patients, remind Thanks. this well perspective the a NASH in what fibrosis? as to from I NASH on you can

Jerry Durso

of approach the reminder the can there perhaps question. you give primary with the endpoint? for Thanks a little Paul,

Paul Nitschmann

this up you, is Thank dataset, patient new It numbers. Yes. longer analysis. We're robust Jerry. patient a more much more as really with a follow viewing

it's exposure. or more XXX actually have who And four now. treatment over been the at patient As more said, by for we're Michelle than subjects twice years looking on

same So analysis, biopsy, at with this these really the we'll liver that Hope new seeing as efficacy we're the helps. a and -- fresh look data.

Ellie Merle

I can? guess statistical the or powering sort if there comment analysis the on in Yes. particular, you of any

Paul Nitschmann

We’ll the original replicate went into analysis. that analyses completely interim the

Ellie Merle

it. Got

Thanks. Okay.

Jerry Durso

Thanks, Ellie.

Operator

Meacham Bank Our of next comes question from Geoff America. with

Aspen Mori

is Thanks the for This questions. guys. Hi, Aspen Geoff. on for

pipeline talk going the data next you OCA combo? some the a the broader higher to dose the on Can the you’ve about? you're lower just any inherent protocol? look thinking the indications study decision, seen actually. there And a part that you. in range FDA about of to informing doses, Thank Is to already you beza kind a then of you be have about do that doses, for Just year? NASH, that you're like that talk both? for asset you're set can is so that Is that that's decision or feedback couple at that for INT-XXX, to far communicate Is or on target list dependent looking of considering maybe that

Jerry Durso

XXX the question. comment perhaps you bezafibrate. can Gail, start for then I Thanks So And on can afterwards. the on

Gail Cawkwell

so. to do happy Sure,

dose important always you going It's doses no to it's regulators of level the doses. from to managing higher OCA Phase bezafibrate low show that something product, you're and complexity, you expects, intend. because combination that FDA are two do course, ranging. than X a and may is a combination ranging, adds of thorough that efficacy other that When doses dose absolutely in do on So that

is regulatory assure study what our progress to and regulatory needs, our have to meet we designed requirements and we So need to program.

so a it range And of includes dose ranging. full

Jerry Durso

Phase progressing So on XXX, is work. We're work the escalation X dose through so ongoing. the

XXXX. in the at are need the of as areas that We several we Michelle expect we'll back interesting indicated may in And remarks, prerecorded but in, of role more focus come is need. select I this some doing And Again, looking to areas we've that us work of work an a that unmet in to interest have would be prepared to the target indication part we position, with next that do. some right first think for as outlined. interesting year now compound unmet feel

Operator

you. Thank

BMO. from Luchini with comes Matt next Our question

Matthew Luchini

hoping Hi. in comprehensive some about be you're for type moving I how ask REVERSE about wanted more Thanks pan reanalysis you. give REVERSE with And resubmission, is the to the and of I question label? potential Thank to for but we were to for the reason about you support I be that of narrow to specifically mean the to thinking would REGENERATE. out forward update. result taking scenario? didn't think just guess that for How consider the a context what you should move or successful, if guess I

Jerry Durso

question. the for Thanks Yes.

As are is clearly also for important I suffering. for dataset the an REVERSE for for patients OCA, field earlier, that I said think and us the

where appropriate previous FDA dialogue REGENERATE Our the in been primarily upon we're process a calls now felt and we to outline we've outlined to kind generate data year this that we getting that focused and to with in point the ourselves now. of on have REGENERATE were able

think closer data, be agency. get we the that and we have data towards as the work regrouping and hand, in with clearly having once I we’ll REVERSE

to work patient's to over we've but in group practitioners. done obviously, the to that years be customer positive, high patient in the it the NASH think at of is an of scenarios. provides is that the healthcare options high different one that us if is concern, in This several the look I Again, that's unmet need. data. tends a way data all the There's And population. themselves, we it's the important good also

how if fit we'd feel see do We'll REVERSE data the all is some we the good positive, have with in data together So pieces hand. optionality.

Operator

you. Thank

with next Our Leerink. Thomas SVB comes from question Smith

Thomas Smith

questions. Maybe just Hi, guys. the here. taking for Thanks a up follow

you As fibrosis response powering for we with the color you've NASH on assumed and primary worsening upcoming think of response the rates trial trial one the a endpoint? pretty placebo on wide REVERSE in range NASH any compensated population. in placebo provide what the about Can no in cirrhotic is readout stage improvement

Jerry Durso

perhaps Paul, pick that one. up you can

Paul Nitschmann

to The the been one expected detail power you. X.X Thank standard what response significance. have was. believe of powering the of placebo not do I read alpha and I this Yes. the XX% was has

Jerry Durso

Thomas, one, we that you can follow with back on up okay.

Thomas Smith

then Yes, just maybe Okay. follow-up question. that be And one would great.

in the Thanks Europe, the REGENERATE guys. I guess provide color the the would any As XXX can the of generation questions wait about on we U.S. reanalysis outcome for Day think and to data the additional you be MAA than rather helpful. decision to respond

Jerry Durso

Thanks.

we're unfolds forward work -- prepared process our towards said Paul, a Maybe, as process plan to response again, through And summary of we as for move give there. As the Michelle questions it the we working we'll can in of current XXX the remarks, us, this month. Day the you the here. kind

Paul Nitschmann

you, Jerry. Thank Yes.

another purely juncture And have into on Does XXX this responses, very at and explanation. could XXX further as in which choose obviously, help? to U.S. to align time. that obviously, to us even could between applicants CHMP ability So Day they Europe. any questions, at not round frequent, hypothetically, the allow withdraw always, datasets the an an point push our of based Day that would ability give our -- is plus could or although They oral opinion minus us

Thomas Smith

guys. Yes, that’s helpful. Thanks,

Jerry Durso

Thanks, Thomas.

Operator

Mamtani next comes Securities. with Our from B. Riley question Mayank

Mayank Mamtani

on the especially team ahead fairing of last both nicely relative reset tracking to expectations bottom Congrats morning. and on year. line, Good and top

the picture the should of of not in and us the kind the -- versus on we cash positive, also flow so see now you as Just market in PBC and impact impact of about quick new can a question sort And we think sustained if that other penetration, that quarters? here XXXX we maybe are you for patients over from the about in but clinical understand this few UN? Andrew, role help next that How start And ongoing. the much dynamics. you're together dynamic Linda the penetration U.S., like think trials outlook end the are can on maybe nearing bring

Linda Richardson

label who was helpful Obviously, very stated, to in you and year And And label our out that Well, the the with education physician I going was on out. the on clarity near Okay. were and the communicating. the also we And went thank we're able base pleased of how we're the communication existing in do representatives that was and end gave in question. there. very change with patient. end believe that with that being for familiar think on transition messaging the the as prescribing by and we who person

of that's shouldn't decompensated through, further Europe that in the as would we impact likely but that there would we in and patients that that course, also indicated in look label label hand, pretty perceive not population. feel much be, on have we don't at So XXXX, we be

we're Now estimated lower to the is it at the when was population available, of really older impact, our look And we we down XX% had end. XX% population. what the finding on

were too they and And fewer we taking on And associated what in once usually a of given were patients. see weekly a -- were expected some was talking some many doses. with approach discontinuations, of were our the decompensated a to doses change taking or customers them dosing. who our customers fewer that to cirrhotic in are we But cautious which compensated to of we were patient realized that had population, twice

feel off. do patients coming that confident are we right So the

we've in waited said that they on back business I much as comments, now focus upcoming is the change. as aware with of COVID the some Now I very new my to over people And depression and periods. frankly, patient seen And were think, previous an label getting -- starts.

conviction can and in data think help when my that we to data product Ocaliva. you drives go from As the on have just change they no would see to second-line how dosing, I what I frankly new in and that's be. we're only product, use product And and regimen this one patient clear, can But a waited the very new sharing, the there. one patients clarity population that's

at in that possible have an as fibrosis. So extension. label ladder And a When that progressive health -- extended stabilization fibrosis at preserving our that is is the look you talk it's POISE resonates open the underlying you you of those When not from underlying and to of important goal. long And see for It patients as data. this a liver physicians, about disease, came element. of we liver the just the higher again ALP.

very AASLD looking can these now think were the that that as data Ocaliva growth much who business. in out support start a of go of there's can I and that And beginning on of a aren’t a comparing market information COBALT see you we at podium communications progression Andrew? return cohort the get earlier to These out and XXXX. their abstract, patients that like and are amount a you coming in to new POISE POISE best take fair this in with patients. the of data growth out, disease, to So patients, presentation were like at

Andrew Saik

Yes. Thanks, Linda.

your answer question as best to try I'll So I can.

Two off, will I'll So and look, expenses. quarters U.S. happy ability in growth/neutrality is to performance really say, international, the just the with cash of and consecutive manage both first we're with sales next our We're not I year, a comments. some prepared win profitability the highlights the underlying terrific give for I of to company. again, PBC franchise. guidance And just for make think, but our

expect that in Michelle to discussed than others we that that So be the and be mentioned increasing indicated also higher have what will this we're prepare help the expenses what and to on next But in I year. we've that remarks, various my quarter, going higher fourth call. prepared this had I datasets than year

the into expenses So is we increase of us we next year expecting to year manage in application prudently. expect FDA, this can the direction to what go with to NASH year. expenses which not our next relative Regardless continue to are you an

also our We PVC will business continue that to expect grow.

conference we helps. the next year that those, guidance So give at end will likely the of very are we we're end. where call I -- with hope we’ll happy at give well, our and year with

Mayank Mamtani

you. helpful. Very Thank

Operator

Thanks.

Oppenheimer. Our next Olson question comes with from Jay

Jay Olson

the quarter on question. Congrats for and the you taking thank Hi.

Can running spoken factors timeline option? about in And and a the then work You’ve about would to maybe talk lead that gating exercise that event you disease profitable that business NASH out? related rare bezafibrate the for doesn't there pursuing a on under combo? for circumstances OCA, you're you that and color that, indication to Thank is opportunity an the would OCA saving you. consider is what PSC XXX any or or when you

Jerry Durso

question, Jay. the for Thanks

all the this is times, we've a which dictate the forward. I of path couple to think is is, As said data center at our going of

forward an path driver in be the in Our decisions. important strategic ultimately NASH

you that imagine any with planning as contingency at can major milestones ongoing. look As you is it's important company,

and we've what take as the importantly, making at to steps right foundation PBC morning, to looked the how with we're solidify we've trying outlined sure this think cost the way tried the debt a remind I doing convertible along standpoint. from we the that this business. been year to management we're Andrew solidifying

foundation make of ensure as the all for data right work to hand right strong And fact the to leverage. is company the strength to the I'm the we this by we always this encouraged So future I decisions. in think importantly get in that have

players. We in deep liver know are the the community. We

commercial R&D around think another liver our of expertise the and success. illustration quarter the I of capability,

use maybe it's we make PSC, me, the for and in company. moving on that phase can our about shareholders. think ensuring company behalf that the on you I the we're on forward readouts. -- again, to decisions the way just And right the that's look of So, to going We're really Gail, next data our the at focused

Gail Cawkwell

Sure. to I'm that. happy take

me So about your let start second XXX. was regards PSC, to with with part, which

PSC alkaline studying with need still on areas, looking an and degree And high we've work is based areas, about which adds a completed in one next we many we X As was our unmet straightforward as there. or area unmet they I We of not will are nice ongoing we saw of in earlier, of reduction, areas. certainly Phase other need PSC, said alkaline pleased. phosphatase as PSC tell year would ran a we're after at are more it's PBC, Unfortunately, some reduction. acid, work biomarkers with number which phosphatase that we area. positive study PSC were and obeticholic is a high agree, but where complexity this

Jay Olson

much. very Great. Thank you

Jerry Durso

Thanks.

Operator

Baird. question next from Our Skorney Brian with comes

Brian Skorney

everyone. for morning, questions Good on any me REGENERATE hear didn't I fitting rereads. Thanks Hi. in.

that. So a on question

more looking value in or at to additional five are But endpoint our statistical addition resolution the X.XX P we wouldn't significance, is the if of saw understand statistical Thanks. focus if endpoint, I significance? at patients evaluated, XXX. or NASH point? even So that for the difference REGENERATE, original just that this to being that wondering question whether think are the the I versus same evaluate given you're just reread you the statistical on on in any not of resolution the is nominal value the able fibrotic NASH on absolute And resolution is remains my and endpoint. P on initial based protocol, the and the if

Jerry Durso

Yes.

no resolution. the worsening primary the into NASH that, on Paul to the And, be both as as obviously, of will on is new we Paul, of earlier, on, that? So readout the patients with said, in was that of NASH you read analysis larger in read indicated number analysis this fibrosis with further it's being than which anything original same methodology. improvement a the two initial the and Paul, the anything want add endpoints

Paul Nitschmann

Not Jerry. really. Thanks,

said, we study As the hasn't changed.

It to speculate. So the too draw patient population, We we as the powering and sample conclusions to you really it can was. therefore size, you will. from early need is it's larger until identical to is that a a data. But wait what see larger

Operator

to the closing of our over back I'd portion call the for Q&A host the turn remarks. concludes This any you. conference. Thank like to

Jerry Durso

objectives shared today. well the conversation the feel today, the good beginning just what of we to we've for set I against year. everybody out that Thanks we the executed Maybe Yes. summarize the in about fact

confident under PBC long ability strong label, our Ocaliva We term. continues new and global to this grow the the remain to in business Our deliver. in with I'm business

commitment I on track to critical but us in allow the successful the least, for our long which I a certainly continue and want foundation, forward. last, believe will important what's we us we serve. their strong pipeline their commercial the term. and the value strengthening made patients we've regarding financial to and regulatory Intercept work forward to not great generation programs support busy activity. clinical, which over The on to advance importantly, period all ability Intercept our a Second, creating decisions providing focus will team we're to continue path look make across execution, in the thank the further the And NASH, Definitely progress data at to dedication allow they're and as shareholder for with their doing the updates

lot So conversation forward a thanks and way. day. Have more we great a to the along look

Operator

this gentlemen, today's Ladies presentation. does and conclude

a You may disconnect, now have and day. wonderful

Intercept Pharmaceuticals (ICPT) 3 Nov 212021 Q3 Earnings call transcript